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Prepstart 200259-00

by Danville Materials, LLC

Ref 200259-00

Prepstart 200259-00 is a device classified as Class IIa in the EU and Class II in the US made by Danville Materials, LLC, registered in EUDAMED on 29 Sep 2026 (Basic UDI-DI 081659402D0302X) and listed in FDA GUDID since 22 Jun 2016 (UDI-DI 00816594021785), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081659402D0302X Basic UDI-DI 00816594021785UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816594021785 UDI-DI Date22 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081659402D0302X registered 29 Sep 2026 Active
  • FDA GUDID UDI-DI 00816594021785 listed 22 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816594021785
  2. Registered EUDAMED 081659402D0302X

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Prepstart
Generic name
Chairside dental abrasive air jet system control unit
Device name
Prepstart System Air Abrasion
Model / Ref / Catalog
200259-00
Primary DI / UDI-DI
00816594021785
Basic UDI-DI
081659402D0302X
FDA product code
KOJ
EMDN code
Q010199 Conservative dentistry and endodontics devices - other
GMDN term
Chairside dental abrasive air jet system control unit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.6080
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental abrasive air jet system control unit

Similar devices in this category

Other devices filed under CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER.

Other devices from Danville Materials, LLC

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Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)